BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MEDIFLEX DRAINAGE BAG

    K Number: K843126 · Decision Oct 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    9
    Review Days
    55

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    Basic Information

    Device Name
    MEDIFLEX DRAINAGE BAG
    K Number
    K843126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mediflex Intl.
    Date Received
    August 10, 1984
    Decision Date
    October 4, 1984
    Product Code
    KNX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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    Other Clearances by Mediflex Intl.

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    K915140 PRIMARY DRESSING TRAY
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    K891077 MEDIVERSE PARENTERAL NUTRITION BAG
    K884243 BLOOD TUBING SET
    K863496 MEDIFLEX TRANSDUCER PROTECTOR
    K855039 MEDIFLEX INJECTION CAP
    K854346 MEDIFLEX DISPOSABLE TUBING CLAMP
    K852106 I.V. ADMINISTRATION SET